U.S. patent application number 11/307751 was filed with the patent office on 2007-08-23 for device for administering cold therapy to ankles.
This patent application is currently assigned to WENDELL-ALAN LTD.. Invention is credited to Max Benton, Jonathan Wendell Flick, Michael Ray Mancias, Jeffrey Alan Wilson.
Application Number | 20070197950 11/307751 |
Document ID | / |
Family ID | 38429265 |
Filed Date | 2007-08-23 |
United States Patent
Application |
20070197950 |
Kind Code |
A1 |
Flick; Jonathan Wendell ; et
al. |
August 23, 2007 |
DEVICE FOR ADMINISTERING COLD THERAPY TO ANKLES
Abstract
A device for administering cold therapy to a human ankle, and a
method for administering cold therapy to a human ankle using the
device. In accordance with the invention, two opposing flexible
sheet members are connected via a web that spans a gap between
them. At least one insert that includes a flexible, fluid-tight
pouch containing at least a chilled, non-gaseous, temperature
retaining fluid is releasably secured to one of the flexible sheet
members. The insert is positioned adjacent to either the lateral or
medial side of the human ankle. Bottom portions of each of the
opposing flexible sheet members are secured to each other
underneath the human's foot. Straps extending from the opposing
flexible sheet members are drawn in opposite directions, one over
the ankle ligaments on the top of the foot and another around the
leg above the ankle, to secure the device to the human's ankle and
thereby provide cold therapy and compression thereto.
Inventors: |
Flick; Jonathan Wendell;
(Mentor, OH) ; Wilson; Jeffrey Alan; (Cleveland
Heights, OH) ; Benton; Max; (Avon, OH) ;
Mancias; Michael Ray; (Cleveland, OH) |
Correspondence
Address: |
RANKIN, HILL, PORTER & CLARK, LLP
925 EUCLID AVENUE, SUITE 700
CLEVELAND
OH
44115-1405
US
|
Assignee: |
WENDELL-ALAN LTD.
1768 E. 25th Street
Cleveland
OH
|
Family ID: |
38429265 |
Appl. No.: |
11/307751 |
Filed: |
February 21, 2006 |
Current U.S.
Class: |
602/65 |
Current CPC
Class: |
A61F 7/10 20130101; A61F
2007/0044 20130101; A61F 13/066 20130101; A61F 2013/00187
20130101 |
Class at
Publication: |
602/065 |
International
Class: |
A61F 13/06 20060101
A61F013/06; A61F 13/00 20060101 A61F013/00 |
Claims
1. A device for administering cold therapy to a human ankle
comprising: a first flexible sheet member having an upper portion,
an intermediate portion and a bottom portion; a second flexible
sheet member having an upper portion, an intermediate portion and a
bottom portion; a web connected to both the first flexible sheet
member and the second flexible sheet member, the web spanning a gap
between the first flexible sheet member and the second flexible
sheet member; a first elastic strap extending from the upper
portion of the first flexible sheet member, the first elastic strap
having an end portion configured to releasably fasten to the upper
portion of the second flexible sheet member; a second elastic strap
extending from the intermediate portion of the second flexible
sheet member, the second elastic strap having an end portion
configured to releasably fasten to the intermediate portion of the
first flexible sheet member; a fastener for releasably securing the
bottom portion of the first flexible sheet to the bottom portion of
the second flexible sheet; and a first insert having a first side
configured to releasably fasten to one of the first flexible sheet
member or the second flexible sheet member, the first insert
comprising a flexible, fluid-tight pouch containing at least a
non-gaseous temperature retaining fluid, the pouch comprising a
pair of spaced apart tubular sections, a lower section spanning the
distance between the spaced apart tubular sections, and a flap
section extending away from the lower section.
2. The device according to claim 1 further comprising a second
insert having a first side configured to releasably fasten to the
other of the first flexible sheet member or the second flexible
sheet member to which the first insert is not releasably fastened,
the second insert comprising a flexible, fluid-tight pouch
containing at least a non-gaseous temperature retaining fluid, the
pouch comprising a pair of spaced apart tubular sections, a lower
section spanning the distance between the spaced apart tubular
sections, and a flap section extending away from the lower
section.
3. The device according to claim 1 wherein the first and second
flexible sheet members are formed of a polymeric fabric.
4. The device according to claim 3 wherein the polymeric fabric is
nylon.
5. The device according to claim 1 wherein the web spanning the gap
between the first flexible sheet member and the second flexible
sheet member is formed of an elastic material.
6. The device according to claim 1 wherein the first elastic strap
is releasably fastened to the second flexible sheet member using a
hook and loop fastening system.
7. The device according to claim 1 wherein the second elastic strap
is releasably fastened to the first flexible sheet member using a
hook and loop fastening system.
8. The device according to claim 1 wherein the fastener for
releasably securing the bottom portion of the first flexible sheet
to the bottom portion of the second flexible sheet is a hook and
loop fastening system.
9. The device according to claim 1 wherein the spaced apart tubular
section, lower section and flap section of the pouch of the first
insert are in fluid communication with each other.
10. The device according to claim 2 wherein the spaced apart
tubular section, lower section and flap section of the pouch of the
first insert are in fluid communication with each other and the
spaced apart tubular sections, lower section and flap section of
the pouch of the second insert are in fluid communication with each
other.
11. The device according to claim 1 wherein the non-gaseous
temperature retaining fluid in the first insert is a water-based
gel having a viscosity greater than that of water and a freezing
point below that of water.
12. The device according to claim 1 wherein the first insert is
releasably fastened to one of the first flexible sheet member or
the second flexible sheet member using a hook and loop fastener
system.
13. A method for providing cold therapy to a human ankle
comprising: providing a device comprising: a first flexible sheet
member having an upper portion, an intermediate portion and a
bottom portion; a second flexible sheet member having an upper
portion, an intermediate portion and a bottom portion; a web
connected to both the first flexible sheet member and the second
flexible sheet member, the web spanning a gap between the first
flexible sheet member and the second flexible sheet member; a first
elastic strap extending from the upper portion of the first
flexible sheet member, the first elastic strap having an end
portion configured to releasably fasten to the upper portion of the
second flexible sheet member; a second elastic strap extending from
the intermediate portion of the second flexible sheet member, the
second elastic strap having an end portion configured to releasably
fasten to the intermediate portion of the first flexible sheet
member; and a fastener for releasably securing the bottom portion
of the first flexible sheet member to the bottom portion of the
second flexible sheet member; fastening a first side of a first
insert to one of the first flexible sheet member or the second
flexible sheet member, the first insert comprising a flexible,
fluid-tight pouch containing at least a chilled, non-gaseous,
temperature retaining fluid, the pouch comprising a pair of spaced
apart tubular sections, a lower section spanning the distance
between the spaced apart tubular sections, and a flap section
extending away from the lower section; positioning an opposing
second side of the first insert adjacent to a lateral side of the
human ankle such that the lateral malleolus is disposed between the
spaced apart tubular sections and the flap section is disposed
adjacent to at least the anterior talofibular ligament; securing
the bottom portion of the first flexible sheet to the bottom
portion of the second flexible sheet underneath the foot; securing
the second elastic strap to the intermediate portion of the first
flexible sheet member such that the second elastic strap wraps over
the top of the foot and provides compression on at least the flap
section of the first insert; and securing the first elastic strap
to the upper portion of the second flexible sheet member such that
the first elastic strap wraps around the leg and provides
compression above the ankle.
14. The method according to claim 13 further comprising: fastening
a first side of a second insert to the other of the first flexible
sheet member or the second flexible sheet member to which the first
insert is not fastened, the second insert comprising a flexible,
fluid-tight pouch containing at least a chilled, non-gaseous,
temperature retaining fluid, the pouch comprising a pair of spaced
apart tubular sections, a lower section spanning the distance
between the spaced apart tubular sections, and a flap section
extending away from the lower section; and positioning an opposing
second side of the second insert adjacent to a medial side of the
human ankle such that the medial malleolus is disposed between the
spaced apart tubular sections.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of Invention
[0002] The present invention relates to a device for administering
cold therapy to ankles and a method of treating an injured ankle
using the device.
[0003] 2. Description of Related Art
[0004] Studies have shown that the most common sports-related
injury is a lateral ankle sprain caused by a sudden, unexpected and
relatively profound inversion of an athlete's foot. Athletes that
participate in the sports of basketball, volleyball, soccer, and
football are particularly susceptible to lateral ankle sprains due
to the amount of jumping, cutting, and pivoting required, and due
to the close body contact between athletes. Lateral ankle inversion
injuries often occur as a result of the athlete's foot landing
awkwardly after a step or jump and/or as a result of the athlete
stepping on another athlete's foot. Many athletes will characterize
an injury of this type as "rolling" their ankle.
[0005] The anatomy of the ankle places the lateral side of the
ankle at a higher risk for sprain injury than the medial side. The
distal end of the fibula (i.e., the lateral malleolus) extends
further inferiorly than the distal end of the tibia (i.e., the
medial malleolus). Thus, there is less bony stability on the
lateral side of the ankle as compared to the medial side of the
ankle. On the lateral side of the ankle, three ligaments provide
stability, namely: the anterior talofibular ligament ("ATFL"); the
calcaneofibular ligament ("CFL"); and the posterior talofibular
ligament ("PTFL"). In a lateral ankle sprain, at least one, and
more typically two or more, of these three ligaments are injured,
with the severity of the injury ranging from a slight degree of
tearing to rupture.
[0006] The generally accepted first aid treatment regimen for a
lateral ankle sprain and other ankle injuries is often referred to
by the acronym "RICE", which stands for rest, ice, compression, and
elevation. Rest is prescribed because continued activity can cause
further injury to the ankle, thereby delaying the healing process,
increasing pain, and stimulating internal bleeding. Ice is
prescribed because blood vessels contract when exposed to cold
temperatures, which helps reduce swelling in the ankle and also
helps to reduce the extent of internal bleeding from injured
capillaries and blood vessels. Compression is prescribed because it
tends to hasten healing time by reducing swelling around injury.
And, elevation of the ankle above the heart is prescribed because
it tends to reduce swelling and also tends to reduce pain.
[0007] Although ice is specifically identified by name in the RICE
acronym, ice is not generally considered to be the best material
for providing cold therapy to ankles. Ice can cause discomfort when
placed between a compressive wrap and an injured ankle because it
is a rigid non-conforming solid material. Furthermore, ice is
difficult to position on an injured ankle, and tends to melt
quickly, which results in a loss of the desired cold treatment
and/or frequent disturbance of the injured ankle to apply more ice.
In view of these and other disadvantages, ice alternatives are
typically used to provide cold therapy treatment to injured
ankles.
[0008] In recent years, temperature-retaining gel-filled thermal
packs have been used instead of ice to provide cold therapy to
injured ankles. The gels used in such packs tend to remain cold for
a longer period of time than ice, and such gels also preferably
remain viscous at low temperatures, which allow them to more
comfortably conform to the contours of the injured ankle when
placed between a compressive wrap and the injured ankle.
[0009] Conventional gel-filled thermal treatment packs generally
consist of a substantially flat flexible envelope that has been
filled with a temperature-retaining gel material. Pre-chilled "flat
packs" of this type are typically pressed into contact with an
injured ankle and over-wrapped with a suitable material such as an
elongated elastic bandage to hold it in place and provide
compression to the injured ankle. Some gel-filled thermal treatment
packs are provided with straps or other means of securing the flat
pack in contact with the injured ankle.
[0010] Flat packs such as described, while widely used to provide
first aid treatment to injured ankles and other limbs, present
certain problems and disadvantages. One problem with flat packs is
that they do not provide targeted cold therapy specifically to the
injured ligaments of the ankle. Such devices are intended for
general use, and thus provide cold therapy to large areas. When
applied to an injured ankle, flat packs administer cold treatment
to non-injured portions of the ankle such as, for example, the
lateral malleolus, which projects away from the ankle. The
application of cold therapy to bony portions of the ankle such as
the lateral malleolus can cause discomfort, which will cause the
athlete to remove the cold therapy and thereby adversely affect
healing of the injured ligaments.
[0011] It will be appreciated that in some instances, the ankle
sprain will occur to the medial ligaments rather than, or in
addition to, the lateral ligaments. In such circumstances, it has
been necessary to apply two flat packs to the injured ankle, which
make placement and retention of the flat packs very difficult. It
is difficult and time consuming to accurately secure a flat pack to
an injured ankle using an elastic wrap, and it is even more
difficult when two flat packs must be secured.
BRIEF SUMMARY OF THE INVENTION
[0012] The present invention provides a device for administering
cold therapy to a human ankle, and a method for administering cold
therapy to a human ankle using the device. In accordance with the
invention, two opposing flexible sheet members are connected via a
web that spans a gap between them. At least one insert that
comprise a flexible, fluid-tight pouch containing at least a
chilled, non-gaseous, temperature retaining fluid is releasably
secured to one of the flexible sheet members. The insert is
positioned adjacent to either the lateral or medial side of the
human ankle. Bottom portions of each of the opposing flexible sheet
members are secured to each other underneath the human's foot.
Straps extending from the opposing flexible sheet members are drawn
in opposite directions, one over the ankle ligaments on the top of
the foot and another around the leg above the ankle, to secure the
device to the human's ankle and thereby provide cold therapy and
compression thereto.
[0013] The foregoing and other features of the invention are
hereinafter more fully described and particularly pointed out in
the claims, the following description setting forth in detail
certain illustrative embodiments of the invention, these being
indicative, however, of but a few of the various ways in which the
principles of the present invention may be employed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a view showing the inner side of a preferred
embodiment of a device for providing cold therapy to ankles
according to the invention.
[0015] FIG. 2 is a view showing the outer side of the device for
providing cold therapy to ankles shown in FIG. 1.
[0016] FIG. 3 is detailed perspective view of a preferred
embodiment of a gel pack for use in a device for providing cold
therapy to ankles according to the invention.
[0017] FIG. 4 is a perspective view of a device for providing cold
therapy to ankles according to the invention disposed on an
ankle.
DETAILED DESCRIPTION OF THE INVENTION
[0018] FIGS. 1 and 2 show the inner side 20 and the outer side 30,
respectively, of the presently most preferred embodiment of a
device 10 for providing cold therapy to a human ankle according to
the invention. The term "inner side", as used in this context,
refers to the side of the device 10 that is positioned adjacent to
a human's ankle when the device 10 is secured thereto, whereas the
term "outer side" refers to the side of the device 10 that is
exposed when the device 10 is secured to a human ankle.
[0019] The device 10 comprises a first flexible sheet member 40 and
an opposing second flexible sheet member 50. The first and second
flexible sheet members 40, 50 are preferably formed of one or more
layers of a fabric material such as woven nylon or canvas, which
can be stitched together to form a flexible sheet. In a preferred
embodiment of the invention, the first and second flexible sheet
members 40, 50 are formed of two layers of nylon sandwiching a thin
closed-cell foam sheet. The perimeter contours of the first and
second flexible sheet members 40, 50 are configured to conform to
and cover either a lateral or medial side of a human's ankle and an
additional area from about mid-foot to the leg above the human's
ankle.
[0020] A web 60 is connected to both the first flexible sheet
member 40 and the second flexible sheet member 50. The web 60
preferably spans a gap or space between the first flexible sheet
member 40 and the second flexible sheet member 50. It will be
appreciated, however, that it is possible to form a device
according to the invention having no gap or space between the first
and second flexible sheet members (i.e., the first and second
flexible sheet members are in contact with each other), or a device
according to the invention wherein the first flexible sheet member
and the second flexible sheet member are formed from a single sheet
of material (i.e., they are integral, and no web spans them). The
web 60 can, but need not be, formed of an elastic material. In the
presently most preferred embodiment of the invention, the web 60 is
formed of an elastic material that stretches in a vertical
direction (i.e., stretchable in a direction parallel to the human's
leg) when the device is secured to a human ankle.
[0021] The first flexible sheet member 40 comprises an upper
portion 70, an intermediate portion 80 and a bottom portion 90.
Likewise, the second flexible sheet member 50 comprises an upper
portion 100, an intermediate portion 110 and a bottom portion 120.
A first elastic strap 130 extends from the upper portion 70 of the
first flexible sheet member 40. The first elastic strap 130 has an
end portion 140 that is configured to releasably fasten to the
upper portion 100 of the second flexible sheet member 50. Hook and
loop fasteners are the preferred means of securing the end portion
140 of the first elastic strap 130 to the upper portion 100 of the
second flexible sheet member 50. Preferably, the loop portion 150
of the hook and loop fastener is attached to the end portion 140 of
the first elastic strap 130 and the hook portion 160 is attached to
the outer side 30 of the second flexible sheet member 50, although
this arrangement is not critical.
[0022] A second elastic strap 170 extends from the intermediate
portion 110 of the second flexible sheet member 50. The second
elastic strap 170 has an end portion 180 that is configured to
releasably fasten to the intermediate portion 80 of the first
flexible sheet member 40. It will be appreciated that the first
elastic strap 130 pulls from one side of the ankle (lateral or
medial) whereas the second elastic strap 170 pulls from the other
side of the ankle. The straps 130, 170 do not cross over each
other, but pull from opposite sides of the ankle around a front
part of the ankle and/or leg. The web 60 is positioned adjacent to
the rear portion of the leg, above the rear portion of the
calcaneus.
[0023] As in the case of the first elastic strap 130, hook and loop
fasteners are the preferred means of securing the end portion 180
of the second elastic strap 170 to the intermediate portion 80 of
the first flexible sheet member 40. Preferably, the loop portion
190 of the hook and loop fastener is attached to the end portion
180 of the second elastic strap 170 and the hook portion 200 is
attached to the outer side 30 of the first flexible sheet member
40, although this arrangement is not critical. The first and second
elastic straps 130, 170 are preferably formed of an elastic
material that is stretchable in a direction away from the
attachment point of the straps 130, 170 to their respective first
or second flexible sheet members 40, 50. The first and second
elastic straps 130, 170 are also preferably relatively wide, having
a width dimension that is greater than or equal to about 3.0
inches.
[0024] The bottom portion 90 of the first flexible sheet member 40
is configured to be releasably securable to the bottom portion 120
of the second flexible sheet member. In the preferred embodiment, a
hook and loop fastener system is used for this purpose. For
example, the hook portion 210 of the hook and loop fastener system
can be stitched or otherwise secured to the outer side 30 of the
bottom portion 90 of the first flexible sheet 40, with the mating
loop portion 220 being stitched or otherwise secured to the inner
side 20 of the bottom portion 120 of the second flexible sheet 50.
The bottom portions 90, 120 of the first and second flexible sheet
members 40, 50 are intended to be fastened to each other beneath
the foot of the human when the device is secured to the human's
ankle.
[0025] At least a first insert 230 is releasably fastened to one of
the first flexible sheet member 40 or the second flexible sheet
member 50. More preferably, a second insert 240 is releasably
fastened to the other of the first flexible sheet member 40 or the
second flexible sheet member 50 to which the first insert 230 is
not releasably fastened. Preferably, the second insert 240 is
identical in size and construction to the first insert 230, except
that it has a mirror image shape. Thus, the following description
of the first insert 230 applies to the second insert 240.
[0026] With reference to FIG. 3, the first insert 230 has a first
side 250 that is configured to releasably fasten to an inner side
20 of one of the first flexible sheet member 40 or the second
flexible sheet member 50. In the preferred embodiment of the
invention, one of a hook portion or a loop portion of a hook and
loop fastening system is secured to the first side 250 of the first
insert 230 (e.g., using adhesive). The mating portion of the hook
and loop fastening system is secured to the inner side 20 of either
the first flexible sheet member 40 or the second flexible sheet
member 50.
[0027] The first insert 230 comprises a flexible, fluid-tight pouch
260 containing at least a non-gaseous temperature retaining fluid.
Throughout the instant specification and in the appended claims,
the term "temperature-retaining fluid" means any non-gaseous
material that changes shape or direction uniformly in response to
an external force imposed upon it and that has the capacity to
transfer cold therapy to an ankle. The term applies not only to
liquids, but also to finely divided solids having such properties.
Preferably, the temperature-retaining fluid is a gel, and more
preferably a water-based gel.
[0028] Water-based gels can be formulated so as to provide a
temperature-retaining fluid that is more viscous than water and
does not become a hard solid within the temperature range of from
0.degree. F. and 32.degree. F. Such gels can conform to the
contours of an ankle more comfortably than ice. In addition, such
gels tend to retain their desired thermal properties for a longer
period of time than ice. The composition of the gel is not per se
critical, but preferably a non-toxic formulation is used to
minimize potential injury in the event of exposure.
[0029] In the presently most preferred embodiment of the invention,
no solids of any kind are dispersed in the temperature-retaining
fluid. However, it will be appreciated that any relatively small
substantially free-flowing solid structure could be dispersed in
the temperature-retaining fluid, if desired. Suitable solid
materials include, for example, water-filled capsules, inorganic
particulates (e.g., sand and/or ceramic particles), spherical
structures (e.g., glass and/or metal spheres), magnets and
combinations thereof. Such structures can be used to extend the
period of time during which the temperature-retaining fluid remains
cold or provide other treatment benefits.
[0030] The pouch 260 is preferably formed between two layers of a
film of flexible material that remains flexible over a relatively
broad temperature range of from about 0.degree. F. to about
70.degree. F. A large number of polymeric films that remain
flexible over such a temperature range are known in the art. It
will be appreciated that polymeric films used in the invention can
be single layer films or multi-layer structures.
[0031] Preferably, the film of flexible material exhibits a Shore A
durometer hardness of greater than or equal to 85 as measured in
accordance with the ASTM 2240.00 standard. More preferably, the
continuous film of flexible material exhibits a Shore A durometer
hardness of 90.+-.5 as measured in accordance with the ASTM 2240.00
standard. Films possessing such properties are advantageously
puncture resistant yet remain flexible.
[0032] Each layer of the film of flexible material can have a
thickness of from about 3 to about 15 mils. More preferably, the
continuous film of flexible material can have a thickness of 5.+-.2
mils. It will be appreciated that film thickness is not per se
critical, and that a variety of film thicknesses can be used to
fabricate a thermal pack in accordance with the invention.
[0033] In the presently most preferred embodiment of the invention,
each layer of the film of flexible material comprises a 5 mil thick
copolymer of polyester and polyurethane having a Shore A durometer
hardness of about 90 as measured in accordance with the ASTM
2240.00 standard. This film provides several advantages. It can be
heat sealed to itself, which facilitates fabrication of the insert
230. It does not irritate human skin on contact. And, it remains
smooth and flexible over the useful temperature range.
[0034] The temperature-retaining fluid is retained in the pouch 260
in the form of a pair of spaced apart tubular sections 270, 280.
The pouch 260 also preferably includes a lower section 290 that
spans the distance between the spaced apart tubular sections 270,
280. The pouch 260 also includes a flap section 300 that extends
away from one side of the lower section 290. Thus, the pouch 260
portion of the insert 230 is generally U-shaped, but features a
flap section 300 that extends from a side of the lower section 290.
Preferably, the spaced apart tubular sections 270, 280, lower
section 290 and flap section 300 of the pouch 260 are in fluid
communication with each other. It will be appreciated, however,
that each section can be formed separate and distinct from the
other sections, as desired.
[0035] The spaced apart tubular sections 270, 280 can be kept in
the proper orientation relative to each other using a bridging
section 310 of flexible film. It is preferable, however, that if a
bridging section 310 is present, an opening 320 is formed between
the bridging section 310 and the lower section 290 of the pouch to
receive the lateral or medial malleolus when the device 10 is
secured to the human ankle. The generally U-shaped pouch 260 allows
for cold therapy to be applied to the ligaments of the ankle. When
applied adjacent to the lateral side of the ankle, the flap section
300 provides cold therapy to the anterior talofibular ligament and
the lower section 290 provides cold therapy to the calcaneofibular
ligament and the posterior talofibular ligament. The tubular
sections 270, 280 apply cold therapy to the peroneal tendon and
other muscles, tendons and soft tissues on either side of the
lateral malleolus that can be strained due to inversion of the
ankle.
[0036] The method for providing cold therapy to a human ankle
according to the invention involves applying a device 10 to the
human ankle. A pre-chilled first insert 230 is fastened to an inner
side of one of the first flexible sheet member 40 or the second
flexible sheet member 50. It will be appreciated that the shape of
the first insert 230 (i.e., the orientation of the flap section
300) and whether the first insert 230 is fastened to the first
flexible sheet member 40 or the second flexible sheet member 50
will be determined by whether the lateral or medial side of the
left or right ankle is to be treated with cold therapy. It is
important that the flap section 300 of the first insert be oriented
toward the front of the foot when the malleolus (lateral or medial)
is disposed between the tubular sections 270, 280 and above the
lower section 290 of the pouch 260. More preferably, a second
insert 240 is also secured to the inner side 20 of the other of the
first flexible sheet member 40 or the second flexible sheet member
50 to which the first insert 230 is not fastened. The flap section
of the second insert must also be oriented toward the front of the
foot when the malleolus (lateral or medial) is disposed between the
tubular sections and above the lower section of the pouch. The
second insert 240 does not necessarily need to be pre-chilled, but
can be used to provide comfort to the wearer. However, in the most
preferred embodiment of the invention, the second insert 240 is
also pre-chilled, and thus the device 10 can simultaneously provide
cold therapy to both the lateral and medial ligaments and lower
soft tissues of the lower leg and ankle. It is possible, but not
preferably, to position one or both of the inserts 230, 240
adjacent to the ankle, and then press the inner side 20 of the
device 10 against the insert(s) 230 240.
[0037] The bottom portion 90 of the first flexible sheet member 40
must be fastened to the bottom portion 120 of the second flexible
sheet member 50. This can be done before the device 10 is
positioned adjacent to the ankle, or after the device 10 has been
placed adjacent to the ankle. Preferably, the device 10 is
positioned such that the lateral malleolus and the medial malleolus
are disposed between the tubular sections 270, 280 of the inserts
230, 240, then the bottom portions 90, 120 of the flexible sheet
members 40, 50 are fastened to each other underneath the foot.
[0038] The second elastic strap 170 is drawn over the top of the
foot and the end portion 180 is secured to the intermediate portion
80 of the first flexible sheet member 40 such that the second
elastic strap 170 wraps over the top of the foot and provides
compression on at least the flap section 300 of the first insert
230. The first elastic strap 130 is drawn around the leg above the
ankle and secured to the upper portion 100 of the second flexible
sheet member 50 such that the first elastic strap 130 wraps around
the leg and provides compression above the ankle. It will be
appreciated that the order in which the straps are secured is not
critical, and that any order can be used. Once the device 10 is
positioned on the ankle, fine adjustments can be made to apply the
desired amount of compression on the desired locations on the ankle
simply by unhooking and rehooking the hook and loop fastening
systems. In some instances, it may be desirable to provide cold
therapy to the top portion of a foot. In such instances, one can
place a conventional pre-chilled flat pack on the top of the foot,
and use the first and second elastic straps to secure the flat pack
on the top of the foot. A flat pack measuring about 3''.times.6''
is particularly suitable for this use.
[0039] It is often desirable to dispose a fabric layer between the
ankle and the insert(s), particularly when the insert(s) have been
pre-chilled. The fabric layer acts as an insulation layer, which
prevents frostbite and prolongs the time the device can be
comfortably worn. The fabric layer can be wrapped around the ankle
prior to applying the device or, more preferably, the device can be
applied over a sock or stocking.
[0040] The device and method for providing cold therapy to ankles
according to the invention is particularly suitable for use in
treating sports related injuries. Several pre-chilled inserts can
be stored in a cooler or other suitable refrigerated container
together with ice or other cold packs in anticipation of being
needed to treat an injury. When an athlete sustains an ankle
injury, one or more insert(s) can be removed from the cooler and
fastened to the inner side of the device, as appropriate. The
athlete can remove his or her shoe, and the device can be applied
immediately to reduce swelling, pain and hasten healing at the site
of the injury. The device can be applied very quickly and very
accurately with little movement of the ankle. Devices and inserts
of various sizes can be kept on hand to treat the ankles of
individuals of various height and age.
[0041] In addition to be useful for treating sports related
injuries, the device according to the invention can be used in a
variety of other applications. For example, the device can be used
in physical therapy, rehabilitation and/or pain relief
applications. Furthermore, the device can be used in geriatric care
and in post-operative recovery. The cooling effect is soothing, and
can be used to provide comfort to individuals who have tired feet
and ankles. Applicants have found that the device not only cools
the ankle areas directly in contact with the pouch or pouches,
after about 10 minutes of use, it also provides soothing relief
virtually to the entire foot and lower leg area. In addition, the
device can be used to provide compression to an ankle only (i.e.,
compression without cold therapy). In such applications, one or
more pouches that have not been pre-chilled are used.
[0042] Additional advantages and modifications will readily occur
to those skilled in the art. Therefore, the invention in its
broader aspects is not limited to the specific details and
illustrative examples shown and described herein. Accordingly,
various modifications may be made without departing from the spirit
or scope of the general inventive concept as defined by the
appended claims and their equivalents.
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